To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
Status
Terminated
Conditions
Lip Augmentation
Treatments
Device: Juvéderm VOLBELLA
Device: YVOIRE Y-Solution 360
Details and patient eligibility
About
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
Full description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area
Enrollment
118 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Male or female 18 years or above age.
- 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
- Agree to use proper contraception as guided in the protocol.
- Signed for Informed Consent.
Exclusion criteria
- have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
- who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
- have undergone oral surgery within 6 weeks
- have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
- have undergone semi-permanent filler in lower face within 24 months
- have undergone temporary dermal filler treatment in the lower face within 12 months
- Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
- Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
- have used lip plumping products within 10 days
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
118 participants in 2 patient groups
YVOIRE Y-Solution 360
Experimental group
Description:
Hyaluronic acid dermal filler
Treatment:
Device: YVOIRE Y-Solution 360
Juvéderm VOLBELLA
Active Comparator group
Description:
Hyaluronic acid dermal filler
Treatment:
Device: Juvéderm VOLBELLA
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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